[Data Link] EUROPEAN MEDICINES AGENCY ; EMA – ID6616 [2020/01/09]

Post Views: 153

https://www.fda.gov/drugs
https://www.fda.gov/drugs

Spark Therapeutics, Inc LUXTURNATM (voretigene neparvovec)
https://www.fda.gov/media/108385/download

glybera assessment report
https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=glybera+assessment+report

Kymriah assessment report
https://www.ema.europa.eu/en/documents/assessment-report/kymriah-epar-public-assessment-report_en.pdf

Zolmoxis assessment report
https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=Zolmoxis+assessment+report

Luxturna assessment report
https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=Luxturna+assessment+report

Strimvelis assessment report
https://www.ema.europa.eu/en/documents/assessment-report/strimvelis-epar-public-assessment-report_en.pdf

reflection paper on design modifications of gene therapy medicinal products during development
https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=reflection%20paper%20on%20design%20modifications%20of%20gene%20therapy%20medicinal

European Medicines Agency
https://www.ema.europa.eu/en/glossary/european-public-assessment-report

Implementing the Principles of Quality by
Design for Early Stage Gene Therapy Products
https://cdn.ymaws.com/www.casss.org/resource/resmgr/WCBP/2012_WCBP_KellyMichael.pdf

Implementing the Principles of Quality by
Design for Early Stage Gene Therapy Products
https://link.springer.com/article/10.1007%2Fs11095-018-2554-7

Hemophilia Gene Therapy: Ready for Prime Time?
https://www.researchgate.net/publication/319049156_Hemophilia_Gene_Therapy_Ready_for_Prime_Time

Development of Safer Gene Delivery Systems to Minimize the Risk of Insertional Mutagenesis-Related Malignancies: A Critical Issue for the Field of Gene Therapy
https://www.researchgate.net/publication/319049156_Hemophilia_Gene_Therapy_Ready_for_Prime_Time

Pharmacokinetic Study of Viral Vectors for Gene Therapy: Progress and Challenges
https://www.intechopen.com/books/viral-gene-therapy/pharmacokinetic-study-of-viral-vectors-for-gene-therapy-progress-and-challenges

Vector design influences hepatic genotoxicity after adeno-associated virus gene therapy.
https://www.ncbi.nlm.nih.gov/pubmed/25607839

Rational Design of Gene Therapy Vectors
https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(19)30012-9

Special delivery by tweaking a virus’s shell, Luk Vandenberghe thinks he can transpaort>>>
https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(19)30012-9

[Data Link] EUROPEAN MEDICINES AGENCY ; EMA – ID6616 [2020/01/09] ID6616

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